US2019231768A1PendingUtilityA1

Pridopidine for treating drug induced dyskinesias

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Assignee: PRILENIA THERAPEUTICS DEV LTDPriority: Sep 8, 2017Filed: Apr 8, 2019Published: Aug 1, 2019
Est. expirySep 8, 2037(~11.2 yrs left)· nominal 20-yr term from priority
A61P 25/14A61K 45/06A61K 31/198A61P 25/16A61K 31/451A61K 9/0053
45
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Claims

Abstract

The invention provides a method of treating a subject afflicted with a drug-induced movement disorder including levodopa-induced dyskinesia comprising periodically administering to the subject in need thereof an amount of pridopidine effective to treat the subject. The invention further provides a method of treating a subject at risk of developing a drug-induced movement disorder, including levodopa-induced dyskinesia. The invention also provides pharmaceutical compositions suitable for carrying out these methods and packages containing such pharmaceutical compositions.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method of treating drug-induced movement disorder (DIMD) in a subject in need thereof, comprising periodically administering to the subject an amount of pridopidine effective to treat the subject. 
     
     
         2 . The method of  claim 1 , wherein the DIMD comprises dyskinesia. 
     
     
         3 . The method of  claim 2 , wherein the dyskinesia is levodopa-induced dyskinesia (LID). 
     
     
         4 . The method of  claim 3 , wherein the subject is afflicted with Parkinson's disease. 
     
     
         5 . The method of  claim 3 , wherein the subject is afflicted with parkinsonism other than Parkinson's disease. 
     
     
         6 . The method of  claim 3 , wherein the subject is concurrently being treated with levodopa. 
     
     
         7 . The method of  claim 6  wherein pridopidine and the levodopa are administered simultaneously. 
     
     
         8 . The method of  claim 7  wherein pridopidine and the levodopa are co-formulated. 
     
     
         9 . The method of  claim 6 , wherein the pridopidine and the levodopa are administered sequentially and in separate pharmaceutical formulations. 
     
     
         10 . The method of  claim 3 , wherein the amount of pridopidine is effective to alleviate or reduce a symptom associated with the levodopa treatment. 
     
     
         11 . The method of  claim 10 , wherein the symptom is abnormal movements, myoclonic jerks, irregular movements of extremities, gait, facial grimacing, ataxia, inability to sustain motor act, hand movement or balance, choreiform peak dose dyskinesia, or dystonic peak dose dyskinesia. 
     
     
         12 . The method of  claim 10 , wherein the symptom is bad quality on-time evoked by levodopa. 
     
     
         13 . The method of  claim 10 , wherein the administration of pridopidine improves the symptom of the levodopa induced dyskinesia by at least 10%, by at least 20%, by at least 30% or by at least 50% as measured by MDS-UPDRS or UDysRS]. 
     
     
         14 . The method of  claim 1 , wherein the pridopidine is administered via oral administration. 
     
     
         15 . The method of  claim 1 , wherein pridopidine is administered once or twice daily. 
     
     
         16 . The method of  claim 1 , wherein the pridopidine is administered in the form of a pridopidine salt. 
     
     
         17 . The method of  claim 16 , wherein the pridopidine salt is pridopidine hydrochloride. 
     
     
         18 . The method of  claim 1 , wherein the pridopidine is administered at a daily dose of 200 mg given in the form of pridopidine HCl. 
     
     
         19 . The method of  claim 1 , wherein the pridopidine is administered at a daily dose of from 45 mg to 400 mg given in the form of pridopidine HCl. 
     
     
         20 . The method of  claim 19 , wherein the pridopidine is administered in equal doses, twice daily. 
     
     
         21 . The method of  claim 1 , wherein the AUC 0-2 4 achieved is about 25,000 h*ng/ml to about 60,000 h*ng/ml. 
     
     
         22 . The method of  claim 1 , wherein the DIMD is induced by a drug selected from an antidepressant, an antipsychotic, an antiepileptic, an antimicrobial, an antiarrhythmic, a mood stabilizer, a gastrointestinal drug or any combination thereof. 
     
     
         23 . The method of  claim 1 , wherein the DIMD is selected from parkinsonism, tardive dyskinesia, chorea, dystonia, tremor, akathisia, athetosis, myoclonus or tics. 
     
     
         24 . The method of  claim 23 , wherein the DIMD is Tardive dyskinesia or drug-induced dystonia. 
     
     
         25 . A method of treating a subject at risk of developing levodopa-induced dyskinesia (LID) comprising periodically administering to the subject an amount of pridopidine effective to delay the onset of LID or reduce the risk of developing LID. 
     
     
         26 . The method of claim  34 , wherein the subject is receiving levodopa for treatment of Parkinson's disease. 
     
     
         27 . The method of claim  34 , wherein the subject is receiving levodopa for treatment of parkinsonism other than Parkinson's disease.

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